Heparin container labels must clearly state the total strength, according to FDA

January 14, 2013

Heparin container and carton labels must now clearly state the total drug strength, according to an FDA Drug Safety Communication.

Heparin container and carton labels must now clearly state the total drug strength, according to an FDA Drug Safety Communication.

This label change will require manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 mL. These modifications will eliminate the need for healthcare professionals to calculate the total amount of heparin medication in a product containing more than 1 mL, thereby reducing the risk of miscalculations that may result in medication errors.

Background information

“In 2003, the United States Pharmacopeia’s (USP) Safe Medication Use Expert Committee became aware of medication errors involving the expression of strength in the labeling for all injectable products. Containers labeled with the strength per mL were often misunderstood as the total drug content, which could result in dosing errors with serious consequences to patients,” according to FDA’s statement.

Heparin is used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures that may increase the chance that clots will form, or to stop the growth of clots that have already formed in the blood vessels and to prevent blood clots from forming in catheters that are left in veins over a period of time.

There will be a transition period before and after the official implementation date on May 1, 2013, during which both the current heparin container labels and the revised heparin container labels will be available in the marketplace. To minimize the potential for medication errors, users should consider separating the supplies of “current” and “revised” labeled heparin, and use all of the supplies of the “current” heparin before using products with the “revised” container label.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.

Download a form or call (800) 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to (800) FDA-0178.